A First in Human, Phase 1/1b Study of Single and Multiple Ascending Dosing Administration of NTX110253 in Healthy Participants and Participants With Stable Schizophrenia
Neurosterix
Summary
This study will assess the safety, tolerability, and pharmacokinetics of NTX-253 following oral administration in both healthy adult participants as well as adult participants with stable schizophrenia.
Description
This study will assess the safety, tolerability, and pharmacokinetics of NTX-253 following oral administration in both healthy adult participants as well as adult participants with stable schizophrenia. NTX-253 is an investigational drug being developed for the treatment of schizophrenia. The study will consist of a single ascending dose (SAD - Part 1a) phase which will include a food effect cohort, and a cerebrospinal fluid (CSF - Part 1b) cohort in healthy volunteers. Participants will receive a single dose of either oral NTX-253 or placebo. The multiple ascending dose (MAD - Part 2) phase w…
Eligibility
- Age range
- 18–55 years
- Sex
- All
- Healthy volunteers
- Yes
Primary Inclusion Criteria: * Male or non-pregnant, non-lactating female participants, ages 18-55 who are not of childbearing potential, with a truly abstinent lifestyle, or agrees to use medically acceptable forms of birth control * Part 1 a/b, Part 2 Cohort 7 only: Body mass index (BMI) within the range ≥18.0 to ≤30.0 kg/m2 * Participants in the food effect cohort must be willing to eat a single high fat breakfast * (Part 2 only): Stable schizophrenia participants (schizophrenia cohorts only) * Body mass index (BMI) within the range ≥17.5 to ≤36.0 kg/m2 * Positive and Negative Syndrome Scal…
Interventions
- DrugNTX-253
Oral Capsule
- DrugPlacebo
Oral capsule
Location
- Collaborative Neuroscience Research, LLC - CenExelLos Alamitos, California